Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Other: Placebo Control; Other: Amniotic Fluid 4.0ml dose; Other: Amniotic Fluid 2.0ml dose

• Registration Number: NCT02768155
• Lead Sponsor: MiMedx Group, Inc.

Brief Summary

A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2017-04
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Subject is 30 years or older.
2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.

Exclusion Criteria

1. Subject has active infection at the injection site.
2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
3. BMI greater than 45 kg/m2
4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
6. Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. Diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Control	Saline Placebo Control
AF 4.0	Amniotic Fluid 4.0ml dose	Amniotic Fluid 4.0ml dose
AF 2.0	Amniotic Fluid 2.0ml dose	Amniotic Fluid 2.0ml dose

Primary Outcome Measures

Name	Time	Method
Reduction in Pain	3 months

Secondary Outcome Measures

Name	Time	Method
Range of Motion	3 month
Knee injury and Osteoarthritis Outcome Score (KOOS)	3 month
WOMAC	3 month
Kellgren-Lawrence grade of OA	6 months

Trial Locations

Locations (2)

Weil Foot, Ankle and Orthopedic Institute; 🇺🇸 Des Plaines, Illinois, United States

Central Research Associates, Inc; 🇺🇸 Birmingham, Alabama, United States